FTC Suffers New Setback in RCT Crusade

Legal and regulatory issues
Rothbard

The Federal Trade Commission’s (FTC) relentless push to establish a legal requirement of drug-level testing for dietary supplements, initiated by the pro-regulatory Obama FTC, appears to be continuing unabated under the supposedly more deregulatory policies of the Trump Administration and its acting FTC head, Maureen Ohlhausen. Depending on one’s perspective, the success of this effort has been “one step forward, two steps back” – or vice versa.

As I’ve written previously, beyond mandating drug-like studies – randomized controlled trials (RCT) – for supplement claims in consent orders, the fruits of the FTC’s RCT enforcement campaign have been decidedly mixed. To review, first, in POM Wonderful, the D.C. Circuit rejected a two-RCT requirement for “disease treatment” claims since it could suppress accurate, useful consumer information in violation of the First Amendment. The court said a single RCT might be justified for disease claims, but for other health claims the more flexible traditional standard of “competent and reliable scientific evidence” would still apply. (FTC Commissioners Fight Over Free Speech and Dr. Oz as Court Settles RCT Debate, February 2015)

Then, in Bayer, a contempt action for violation of a consent order, the district court rejected the government’s claim that “competent and reliable scientific evidence” necessarily dictates an RCT to substantiate dietary supplement claims, stating that “as long as a supplement is not marketed as a drug, it is not regulated like a drug.” (FTC Suffers Another Setback in RCT Crusade, November 2015)

After these losses, the FTC bounced back with a win in COORGA Nutraceuticals, getting the court to accept its expert’s testimony and hold that at least one RCT was required to support a gray hair remedy claim. COORGA did not have an RCT and it made the FTC’s and the court’s job a lot easier by not offering an expert of its own on the issue. (FTC Back on Track in RCT Crusade, September 2016)

Undeterred by its defeats in POM and Bayer, and perhaps emboldened by its victory in COORGA, the FTC has continued its RCT crusade, most recently in a case involving cognitive claims for Prevagen, a brain health supplement manufactured and sold by Quincy Bioscience. Issued by the outgoing Democratic majority during the presidential transition without the participation of Ohlhausen, but vigorously defended by FTC counsel under her leadership, the complaint alleges that a claim that Prevagen helps with mild age-related memory problems is false and unsubstantiated even though the claim is based on an RCT.

While presumably pleased that an RCT underlay the claim, and finding no fault with the design or execution of the study itself, the FTC still thought it necessary and worthwhile to take Quincy to federal court because the results of the study as a whole were not statistically significant on any of the cognitive tasks. The claim, though, was not based on the study results as a whole but on statistically significant results found upon deeper analysis within two subgroups of individuals with normal or only mildly impaired age-related memory loss. These findings still didn’t get the claim over the FTC finish line, though, because they were based on so-called “post hoc subgroup analysis” that, according to the complaint, “greatly increases the probability that the statistically significant improvements shown are by chance alone” and “do not provide reliable evidence of a treatment effect.”

Believing the FTC’s position, as alleged, was unsustainable, Quincy moved to dismiss the complaint on the ground that it failed to state facts to support the generalized allegation that subgroup analysis is unreliable, and that nowhere in FTC guidance is such mode of analysis called into question or disallowed in any way. Agreeing, the judge granted the motion in late September, observing that the Prevagen RCT represented the “gold standard” in clinical research and concluding that the complaint failed because it does no more than:

“…point to possible sources of error [in subgroup analysis] but cannot allege that any actual errors occurred … plaintiff’s challenge never proceeds beyond the theoretical. They say that findings based on post hoc exploratory analyses have an increased risk of false positives, and increased probability of results altered by chance alone, but neither explain the nature of such risks nor show that they affected the subgroups performance in any way or registered any false positives. Nor do they give any reason to suspect that these risks are so large in the abstract that they prevent any use of the subgroup concept, which is widely used in the interpretation of data in the dietary supplement field. Thus, the complaint fails to show that reliance upon the subgroup data ‘is likely to mislead consumers acting reasonably under the circumstances,’ as is necessary to state a claim.”

As of this writing, the FTC has not amended its complaint. If it does – versus trying to talk Quincy into settling after digesting the court’s opinion – it will be interesting to see how the FTC’s challenge is able to move from the “theoretical” to the real and give the court an actual reason to think that statistically significant results from subgroup analysis may “not provide reliable evidence of a treatment effect.”

More broadly, it also will be interesting to see whether the FTC’s quest to make drug-level testing the “law of the land” for dietary supplements will continue in full force or be reevaluated by President Trump’s three new FTC appointees, whose nominations finally have been submitted to the Senate to fill the current vacancies. As a federal judge now has held, the FTC goes too far when it takes to task a dietary supplement company that has done the kind of “gold standard” testing it wants to see, and crunched the numbers in a commonly accepted way, but not in a way the FTC endorses. At the very least, before continuing its quest or even mandating RCTs in future settlements, the new FTC leadership must update the agency’s guidance, which doesn’t even say that RCTs are required to substantiate supplement claims.

Ohlhausen has called for such a review and hopefully her new colleagues will support it – and even seek public comment on what the new guidance should be. For too long, the FTC has made dietary supplement substantiation policy by fiat, imposing its preference for drug-like standards in an ad hoc manner through case-by-case enforcement. It’s time that the industry, consumer advocates, and the clinical research community have a chance to have their voices heard – in a systematic manner – in the policymaking process. Even if the new substantiation guidance that emerges is too rigid for the industry’s liking, at least it will feel it had input, which – for far too long – has not been the case.